FDA:Expansion of the Abbreviated 510(k) 2 Program


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"The draft guidance provides details on which devices would be considered appropriate for the new option based on intended use and technological characteristics, how FDA intends to identify performance criteria for the purposes of making final substantial equivalence determinations, as well as what the expectations are for device makers submitting data for FDA review via this program.

For example, the agency said it “expects a submitter to demonstrate that the new device meets the FDA-identified performance criteria by submitting a declaration of conformity, a summary of the data, and/or underlying data, as appropriate.”



Involved In Discussions
Can someone provide a gap analysis or summary report to the new FDA abbreviated 510(K) guidance. I just want to access if our QMS needs to be updated. Please share yours if you have. Thanks!

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